Increasing PrEP With Trans Women in the Deep South (T'Cher)

CrescentCare

Status: Enrolling

Conditions: Hiv

Treatments: Behavioral: Peer PrEP Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT05689281

10275

Details and patient eligibility

About

The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single arm stepped wedge clinical trial. The main question is to compare PrEP uptake and adherence outcomes among trans women in the T'Cher intervention to the delayed study arm.

Full description

The intervention will also assess changes in health care empowerment and support for Social Determinants of Health (SDoH) as mediating the effect of the intervention on PrEP uptake and adherence among trans women.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed and dated informed consent form
• Declaration of willingness to comply with all study procedures and availability during the study
• Age 18 years old or older
• Male sex designated at birth
• Identify as trans woman, woman or another gender identity not associated with being a man
• Desire to use or re-start PrEP
• HIV uninfected
• Speaks English or Spanish
• Live in the New Orleans metropolitan statistical area (which includes 8 parishes)

Exclusion criteria

• Confirmed HIV infection by rapid algorithm testing and/or laboratory testing (described above)
• Prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity
• Concurrent or planned enrollment in a research study that provides PrEP
• Unwilling to attend quarterly follow-up visits, which will include survey participation
• Has any other condition which, based on the opinion of the investigator, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

PrEP peer navigation

Experimental group

Description:

Culturally informed health care empowerment and PrEP peer navigation and support through social determinant of health stressors

Treatment:

Behavioral: Peer PrEP Navigation